Clinical efficacy and safety of transcutaneous acupoint electrical stimulation combined with proton pump inhibitors in the treatment of laryngopharyngeal reflux disease

Clinical efficacy and safety of transcutaneous acupoint electrical stimulation combined with proton pump inhibitors in the treatment of laryngopharyngeal reflux disease:a randomized controlled trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2100004891

Enrollment

Unknown

Registered

2021-05-28

Start date

2021-06-15

Completion date

Unknown

Last updated

2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

laryngopharyngeal reflux disease

Interventions

Group 2:Proton pump inhibitor

Group 1:Transcutaneous electrical acupoint stimulation + proton pump inhibitor

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years; 2. Symptoms of foreign body sensation in the throat for more than 6 weeks, continuous throat clearing, hoarseness, fatigue of pronunciation, sore throat, chronic cough, dyspnea and other symptoms; 3. Patients with RSI>13 points and/or RFS>7 points, Dx-ph monitoring diagnosed as acid reflux; 4. The patient signs an informed consent form and agrees to participate in the clinical trial.

Exclusion criteria

Exclusion criteria: 1. The diagnosis is considered to be pharyngeal discomfort caused by bacterial or viral pharyngitis; 2. Upper gastrointestinal endoscopy or laryngoscopy found erosive gastroesophageal reflux, laryngeal cancer, esophageal cancer, gastric cancer and other diseases; 3. History of esophagus or stomach surgery, history of neck radiotherapy; 4. Severe liver, kidney and other organ dysfunction, unable to tolerate medications or allergic to medications; 5. Have used proton pump inhibitor therapy or other research drugs in the previous month; 6. Patients who are pregnant or breast-feeding; 7. RSI scale score (excluding the ninth item) <10 points; 8. Patients taking clopidogrel or warfarin; 9. Contraindications for transcutaneous electrical acupoint stimulation (TEAS): such as acupuncture points to stimulate skin rash or local infection or implantation of a pacemaker or defibrillator, electrode pads cause skin allergies or itching, etc. and patients suffering from acute diseases, infectious diseases, malignant tumors, cardiovascular and cerebrovascular diseases or other malignant diseases.

Design outcomes

Primary

Measure	Time frame
visual analogue scale;reflux finding score;reflux symptom index;	—

Secondary

Measure	Time frame
LPR-HRQL scales;Dx-ph monitoring;	—

Countries

China

Contacts

Public ContactLiu Yehai

The First Affiliated Hospital of Anhui Medical University

liuyehai@ahmu.edu.cn+86 13856906986

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026